FDA Announces First Ever at Home HIV Test

In the never-ending war against the spread of the HIV virus that can lead to AIDS, the Food and Drug Administration announced Tuesday that it has approved the first-ever a self-administered HIV testing kit that produces results without the use of a laboratory.

According to a press release by the FDA, the OraQuick In-Home HIV test is designed to allow a person to collect an oral fluid sample by swabbing the upper and lower gums inside of their mouths, and then by placing the sample into a developer vial, they can see test results within 20-40 minutes.

While this test and other future advancements in home HIV testing will help control the spread of the virus, OraSure Technologies, the manufacturer of OraQuick, says that results of this test neither confirm nor disprove an individual’s infection status with HIV, but rather that additional testing should be conducted in a medical setting in order to verify the result.

“Knowing your status is an important factor in the effort to prevent the spread of HIV,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate.”

In clinical studies for self testing, OraQuick In-Home HIV Test has a performance rate of 99.98 percent for specificity, which is the percentage of results that will be negative when HIV is not present. What this means is that one false positive is possible for every 5,000 test results in uninfected individuals, according to the release.

Consumers will have access to customer support 24 hours a day, seven days a week, which will be available to educate users about HIV/AIDS as well as assist them in the proper methods for using the test.

The Centers for Disease Control and Prevention estimates that 1.2 million people in the United States are living with HIV infection – One in 5 are not aware they are infected.

OraQuick In Home HIV Tests should be on sale online and at 30,000 retail outlets by October of this year.